Drug products: Lansoprazol 2care4, Lansoprazol Actavis, Lansoprazol Arrow, Lansoprazol Bluefish, Lansoprazol Ebb, Lansoprazol Krka, Lansoprazol Medical Valley, Lansoprazol Mylan, Lansoprazol Pensa, Lansoprazol ratiopharm, Lansoprazol Stada, Lansoprazol SUN, Lansoprazol Teva, Lanzo, Limpidex, Nixacid, Zoton
ATC code: A02BC03
Proton pump inhibitors (PPI) decrease the acid secretion leading to increase in the serum levels of gastrin. One study has shown that women treated with PPI had higher serum levels of gastrin compared to men both before and after meals. In persons not treated with PPI this differences between men and women was not found. This indicates that women are more sensitive to the acid secretion effect of PPI. The clinical relevance of this is unknown.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
No clinically relevant pharmacokinetic differences between men and women have been found. A pharmacokinetic study has compared lansoprazole and its inactive metabolites, 5’-hydroxy lansoprazole and lansoprazole sulfone. Healthy Chinese volunteers (6 men, 6 women) received single and multiple intravenous doses of 30 mg lansoprazole for 6 days. Women had higher Tmax of both metabolites than men. Volume of distribution for lansoprazole was higher in women, but when adjusted for body weight, the sex difference disappeared . A similar study by the same authors but with single doses of lansoprazole (15, 30 or 60 mg i.v.) reported no sex differences in pharmacokinetics of lansoprazole and its two metabolites, except for Cmax .A randomized double-blind study (32 boys, 31 girls) evaluating lansoprazole pharmacokinetics in adolescents between 12-17 years of age with gastroesophageal reflux disease showed no sex differences .
Based on the pharmacokinetic findings, dosage adjustment according to sex should not be needed. No clinically relevant sex analysis regarding dosing of lansoprazole has been found.
The effect of long-term proton-pump inhibitor (PPI) treatment on serum gastrin concentrations after a meal has been evaluated in PPI users (56 men, 44 women) and PPI non-users (25 men, 25 women). Female patients had higher gastrin levels than males before and after the meal, whereas such sex differences were not found in the control group. Female patients also had higher chromogranin A values than males. High chromogranin A levels are seen in patients using proton-pump inhibitors. Female sex was the only independent predictor of elevated fasting gastrin values (OR 2.50, 95%CI: 1.08-5.76). No difference was observed between men and women in terms of BMI or dosage and the duration of PPI therapy. This indicates that women could be more sensitive than men to the inhibitory effects of acid secretion on gastrin release. However, it is unclear whether this is a clinically important sex difference .The effect of lansoprazole on health-related quality of life (HRQOL) in patients with clinical symptoms of reflux oesophagitis has been investigated in a Japanese study (3531 men, 5226 women). Patients received 15 or 30 mg/day for 8 weeks. HRQOL was assessed using a health survey and a specific questionnaire for reflux oesophagitis. Physical and mental component summary scores were improved after lansoprazole treatment to a similar extent in men and women .
Hypersensitivity reactions to PPIs (omeprazole, lansoprazole, pantoprazole, esomeprazole and rabeprazole) have been evaluated in a literature review. Omeprazole was most frequently associated with hypersensitivity reactions. Overall, most hypersensitivity reactions were reported in women (61%) . Sex-stratified data were not presented for each PPI.A retrospective study of PPI-induced subacute cutaneous lupus erythematosus (SCLE) has been carried out over a 19-year period. Nineteen women and two men were identified through medical records. PPIs associated with SCLE were lansoprazole (12 patients), omeprazole (6 patients), esomeprazole (4 patients) and pantoprazole (2 patients) .A prospective observational study investigating the incidence of headache in lansoprazole users showed that women reported more headache than men (odds ratio 1.6) .
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Regression of Barrett’s esophagus, a consequence of long-standing gastro-esophageal reflux, with long-term PPI therapy has been analyzed (188 patients). Patients were either taking a lower PPI dose (20 mg omeprazole daily or 30 mg lansoprazole daily) or a higher PPI dose (40 mg omeprazole or 60 mg lansoprazole). Partial re-epithelialization in the form of squamous islands was related to the duration of PPI therapy (risk ratio 0.43) and male sex (risk ratio 1.4) .Treatment patterns of PPI in patients with newly diagnosed gastroesophageal reflux disease have been analyzed in a British study. PPI prevalence was higher in women (25.2/1000 inhabitants vs 21.7/1000 inhabitants) .
Date of litterature search: 2015-04-16
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson